Universal- Versus Guidelines-Directed Genetic Testing for Germline Pathogenic Variants Utilizing a Multi-Gene Panel for Inherited Cancers in Non-Western Society.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- King Hussein Cancer Center
- Enrollment
- 3,000
- Locations
- 1
- Primary Endpoint
- Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing
Study Overview
Brief Summary
The investigators aim to study the pattern and frequency of pathogenic variants among ALL newly diagnosed cancer patients in a genetically distinct population.
Additionally, the investigators will study the uptake rate of "cascade family screening", frequency of pathogenic variants and barriers against testing.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient, age ≥ 18 years at time of cancer diagnosis
- •Pathology proven diagnosis of cancer; any site, any stage (prior history of cancer is allowed)
- •Jordanian nationality
- •Willingness to participate
- •Signed consent form
Exclusion Criteria
- •Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications)
- •Non-Jordanian
- •Patients with Leukemia, Lymphoma and Myeloma
Outcomes
Primary Outcomes
Number of participants with variants of uncertain significance (VUS) as assessed by universal multigene panel testing
Time Frame: 2021-2023
To determine the reasons/ Barriers for refusal of genetic cascade testing among newly diagnosed cancer patients.
Time Frame: 2021-2023
Prevalence of pathogenic or likely pathogenic germline variants among newly diagnosed cancer patients tested by universal multigene panel testing
Time Frame: 2021-2023
Secondary Outcomes
- Rate of cascade of family member testing of the participants with positive pathogenic mutation(2021-2023)
- To determine the reasons/ Barriers for refusal of genetic cascade testing among family members of tested patients with pathogenic mutation(2021-2023)
- Prevalence of variants of uncertain significance (VUS) among tested family members of participants with pathogenic mutations as assessed by universal multigene panel testing(2021-2023)
- Prevalence of pathogenic or likely pathogenic mutations among tested family members of the participants with pathogenic mutations using the universal multigene panel(2021-2023)
Investigators
Hikmat Abdel-Razeq
Professor, Chairman of department of medicine, Chief Medical officer, Deputy Director General
King Hussein Cancer Center